Development and Expectations
The and HHS announced a "next-generation, universal vaccine platform" aiming for a universal COVID-19 and influenza shot, eliminating the need for annual updates. Clinical trials are set for 2026, with a target availability by 2029.
This initiative, termed Generation Gold Standard, represents a significant shift towards strain-non-specific vaccine protection, leveraging traditional vaccine technology modernized for future flu viral threats.
Regulatory and Developmental Insights
Moderna's mRNA‐1083, a candidate for the joint vaccine, showed positive Phase 3 testing results in June 2024, with an extended review timeline aiming for 2026 approval following FDA feedback.
The FDA, after canceling a scheduled meeting of the Vaccines and Related Biological Products Advisory Committee, relied on its own staff for guidance on the 2025-26 flu vaccine, amidst concerns over HHS cuts affecting vaccine availability.